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Re: ....patent expired chemist

Posted by Larry Hoover on May 12, 2005, at 22:56:00

In reply to .... Chairman_MAO, posted by chemist on May 12, 2005, at 11:56:42
> which is easily reached (CDER Archives) from there, you can actually locate the drug Eldepryl, and learn about the NDA/ANDA/BLA business (and other meaningful acronyms), and make an informed decision.

I see all kinds of ANDA applications approved in the period of 96-98. Obviously, the stuff is off patent. Does the delivery system make Emsam a new drug?

If I'm not mistaken, the transdermal route is supposed to avoid first-pass metabolism, and thus avoid the whole tyramine thing (i.e. the protective enzymes in the gut are spared, leaving them "on guard" against ingested tyramine). Is it that this mechanism isn't proved? Or that nobody wants to stick their neck out in this particular legal/political climate? It's not a medical issue, is it? I don't think so.

And so, I leave loose ends, and off to bed.





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